NCT04662034

Performance and Safety of the Cardiac Microcurrent Therapy System

Prospective, Randomized, Open, Comparison Study to Demonstrate the Performance and the Safety of Cardiac Microcurrent Therapy (C-MIC) System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Berlin Heals GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Patients with idiopathic dilative cardiomyopathy who have systolic left ventricular dysfunction (NYHA III - IV) despite adequate therapy according to treatment guidelines of heart failure and who have a baseline left ventricular ejection fraction of ≥25% and ≤35 will receive a C-MIC System and microcurrent therapy after device implantation with optimal medical management. At the end of the study after 6 months, the C-MIC System will be turned off. The control group will receive optimal medical management without device implantation.

Detailed description

Target patients for the C-MIC System are patients with idiopathic dilative cardiomyopathy who have systolic left ventricular dysfunction (NYHA class III - NYHA class IV) despite adequate therapy of heart failure and a left ventricular ejection fraction ranging from 25% to 35% with a history of heart failure of more than 1 year but less than 5 years. The study's objective is to determine the safety and effectiveness of C-MIC therapy in patients with moderate to severe heart failure under optimal medical therapy. Data from a pilot study (C-MIC-I) indicate that an increase of ≥ 8% of the left ventricular ejection fraction can be achieved within a treatment period of 6 month. Therefore, the study hypothesis assumes hat the change in LVEF from baseline to 6 months will be significantly greater in patients undergoing C-MIC therapy (device group) in addition to guideline directed medical therapy (GDMT) compared patients remaining on GDMT alone (control group). Subjects will be randomized in a 1:1 ratio to receive the C-MIC System in addition to optimal medical management or to receive optimal medical management alone without device. Due to the risks associated with the implantation, a sham (placebo) procedure is not warranted. The primary endpoint will be measured as the difference in the change in LVEF from baseline to 6 months, measured via cardiac ultrasound and expressed in percentage. LVEF measurements will be compared between the device and control groups and verified by a core lab at baseline, week 4, month 4 and month 6.

Conditions

• Systolic Left Ventricular Dysfunction

Interventions

Type	Name	Description
DEVICE	CMIC	The C-MIC System consists of three implantable parts: a transvenous and an epicardial lead which are both connected to an implanted power source, and an external programing device. The patch lead is placed over the free wall of the left ventricle and fixated with sutures. When lead placement is achieved, the leads are then tunneled subcutaneously to the infraclavicular region and connected to the power source.
DRUG	Standard of Care (SOC)	Patients receive optimal SOC based defined in pertinent guideline and at the discretion of the investigator

Timeline

• Start date: 2021-02-05
• Primary completion: 2024-11-13
• Completion: 2024-11-13
• First posted: 2020-12-10
• Last updated: 2026-02-06

Locations

20 sites across 11 countries: Bosnia and Herzegovina, Bulgaria, Croatia, Czechia, Germany, Greece, North Macedonia, Poland, Serbia, Spain, Switzerland